A Comparative Study of Percutaneous Pulsed Field Ablation Guided by Ultrasound Alone Versus Fluoroscopy in Patients With Atrial Fibrillation

N/ANot Yet RecruitingNCT07762742

China National Center for Cardiovascular Diseases276 enrolled

Overview

This prospective, randomized, multicenter, open-label, non-inferiority interventional study aims to compare the therapeutic efficacy of percutaneous pulsed field ablation (PFA) guided by ultrasound alone versus fluoroscopy in patients with paroxysmal atrial fibrillation (AF). The success rate of complete electrical isolation of pulmonary veins during the procedure was compared to verify that ultrasound-only guidance is non-inferior to fluoroscopic guidance.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

276

Conditions

Paroxysmal Atrial Fibrillation (PAF)

Interventions

Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients aged 18 to 75 years (including 18 years and 75 years of age). * Patients diagnosed with paroxysmal atrial fibrillation via 12-lead electrocardiography or ambulatory electrocardiography and scheduled to undergo pulsed field ablation. * Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program. Exclusion Criteria: * Atrial fibrillation secondary to electrolyte imbalance, thyroid disorders, or reversible non-cardiac causes; * Previous history of catheter ablation or cardiac surgery for atrial fibrillation; * Prior surgical history including patent foramen ovale closure, atrial septal defect closure or repair; * Implantation of left atrial appendage occluder, mechanical mitral valve prosthesis, or valvuloplasty ring containing metallic materials; * Concomitant other tachyarrhythmias requiring catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, atrial tachycardia, atrial flutter, Wolff-Parkinson-White syndrome, etc.); * Persistent atrial fibrillation; * Left atrial anteroposterior diameter (LAD) \> 55 mm on transthoracic echocardiography; * Women who are pregnant, breastfeeding, or of childbearing age with plans to become pregnant during the clinical trial; * Current participation in another pharmaceutical or medical device clinical study.

Outcomes

Primary Outcomes

Success rate of complete electrical isolation of pulmonary veins during the procedure

The proportion of all pulmonary veins maintaining bidirectional block across ablation lines at 20 minutes after ablation completion.

Time frame: Immediately post-procedure

Secondary Outcomes

The incidence of complications within 30 days after the procedure

Observe the proportion of complications occurring within 30 days after the procedure. Such complications include pericardial effusion or cardiac tamponade requiring drainage, phrenic nerve palsy lasting more than 24 hours, severe vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula, and death.

Time frame: Within 30 days post-procedure

Success rate of atrial fibrillation ablation at 12 months post-procedure.

Defined as the absence of AF, atrial flutter (AFL), or atrial tachycardia (AT) episodes ≥30 seconds on dynamic electrocardiogram (ECG) monitoring after the blanking period (90 days post-catheter ablation)